This study is undertaken to generate clinical data on GSK Biologicals' combined measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from newly established working seed viruses which are one passage further than the current working seed viruses. The measles-mumps-rubella-varicella vaccine manufactured with the current working seed viruses will serve as comparator.

A seed lot system is a system according to which successive batches of a vaccine are derived from the same master seed virus. For routine production, a working seed lot is prepared from the master seed virus.

Seroconversion rates for measles, mumps, rubella and varicella [ Time Frame: approximately 42-56 days after the first dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measles, mumps, rubella and varicella seroconversion rates [ Time Frame: 42-56 days after the second dose ] [ Designated as safety issue: No ]

Measles, mumps, rubella and varicella antibody titres [ Time Frame: 42-56 days after the first and second doses ] [ Designated as safety issue: No ]

Occurrence of any and any grade 3 (severe) solicited local symptoms (injection site redness, pain and swelling) [ Time Frame: within four days after each vaccination (Day 0-3) ] [ Designated as safety issue: No ]

Occurrence of any and any grade 3 (severe) solicited general in terms of fever, rash, any sign of meningitis including febrile convulsion and parotitis [ Time Frame: symptoms within 43 days after each vaccination (Day 0-42) ] [ Designated as safety issue: No ]

Occurrence of unsolicited symptoms [ Time Frame: within 43 days after each vaccination (Day 0-42) ] [ Designated as safety issue: No ]

Occurrence of serious adverse events [ Time Frame: from the first study vaccine dose up to study end ] [ Designated as safety issue: No ]

Vaccine will be administered subcutaneously in the left upper arm (deltoid region)

Eligibility

Ages Eligible for Study:

11 Months to 21 Months (Child)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.

A male or female between, and including, 11 and 21 months of age (e.g. from age 11months until the day before age 22 months) at the time of the first vaccination.

Written informed consent obtained from the parent or guardian of the subject after they have been advised on the risks and benefits of the study in a language they clearly understand, and before performance of any study procedure.

Free of obvious healthy problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.

Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to until 42 days after each study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time and routine inactivated vaccines such as pneumococcal, meningococcal or Haemophilus influenzae type b conjugate vaccines, inactivated influenza or diphtheria/tetanus containing vaccines which can be administered up to eight days before each study vaccine dose.

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.

Major congenital defects or serious chronic illness.

History of any neurologic disorders or seizures.

Acute disease at the time of enrolment.

Rectal temperature ≥38°C or axillary temperature >=37.5°C at the time of vaccination.

Residence in the same household as a high risk person e.g.:

New-born infants (0-4 weeks of age)

Pregnant women who have a negative history of chickenpox

Persons with known immunodeficiency

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892775